BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2925352 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00829
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V198619, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE PATIENT TOOK A FLIGHT ON (B)(6) 2012, SHE HAD BEEN FEELING STIMULATION IN HER FEET. ON THE DAY PRIOR TO THE REPORT, THE PATIENT STARTED TO LOSE URINARY RELIEF. THE PATIENT WAS PREVIOUSLY ON PROGRAM 1 AT 0.50V, AND HAD TURNED STIMULATION OFF TWO DAYS PRIOR TO THE REPORT. ON THE DAY OF THE REPORT, SETTINGS WERE SWITCHED TO PROGRAM 2 AT 0.25V WHERE THE PATIENT FELT STIMULATION IN HER BICYCLE SEAT AREA. HOWEVER, THE PATIENT WANTED TO SWITCH BACK TO A DIFFERENT PROGRAM AND TURN STIMULATION OFF UNTIL SHE SAW HER HEALTHCARE PROVIDER (HCP) THE FOLLOWING WEEK. THE REPORTER INDICATED THAT THE PATIENT COULD STILL FEEL STIMULATION EVEN THOUGH STIMULATION WAS CONFIRMED TO BE OFF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31451 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1